Clinical Research Associate

The Role

The CRA involves in the study preparation, planning, implementation,conduct site visits, follow up the clinical academic study to ensure itadheres to regulatory and ethical standards and deliver the study withintimeline.

Reporting Relationships

The Clinical Research Associate functionally reports to the ProjectManager for project specific responsibilities. The position may bementored and guided by Senior Clinical Research Associates.

Duties and Key Responsibilities

Study Design

Coordinate the identification, feasibility assessment and selection ofinvestigators and sites to undertake the study
Prepare, plan, organize and conduct pre-study (site selection) visitsand report on these visits to assist in site selection
Prepare for, plan, organize and conduct site initiation visit
Assist in the development of appropriate monitoring tools
Motivate and train investigators and ensure that the study sitepersonnel have a good understanding of the protocol, and therequirements of the study and that they can fulfil their obligations toconduct the study accurately and to deadlines.

Study Execution

Motivate investigators and ensure that the study site personnel enrolthe target number of eligible subjects within timeline
Verify quality, completion, and timeliness of data.
Completely and efficiently resolve data and audits queries and issues.
Adhere to the study protocol and study procedures manual.
Adhere to ICH/GCP and other regulatory guidelines and requirements asrelevant to this trial including reporting of adverse events/seriousadverse events are reported
Assist participating centre research staff in the local management ofthe study where required.

General

Manage effective communication with the key stakeholders (outsidevendors, Research Coordinators, etc).

Skills, Knowledge, and Experience

Education/ Research Background
Tertiary qualifications in a related science or health care discipline,research background with post-graduate qualifications preferred.
2 years experience in clinical operation within an academic, CRO orpharmaceutical environment.
Excellent working knowledge of ICH/GCP, ethical and regulatory requirements
Excellent interpersonal skills, presentation skills and the ability towork well and flexibly ie autonomously, in teams and with a wide rangeof varying stakeholders
Excellent organizational skills – ability to organize, take initiativeand follow up independently